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CompletedLast updated: 20 December 2023

NALA: This phase III trial is comparing the combination of neratinib and capecitabine, with lapatinib and capecitabine, in the treatment of people with HER + metastatic breast cancerA Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting (Other ID's:PUMA-NER-1301, 2012-004492-38)

Clinical summary

Summary

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.

Conditions

This trial is treating patients with HER 2 + breast cancer.

Cancer

Breast Cancers Breast

Age

People18 - 75

Phase

III

Trial Acronym

NALA

More information

Trial Identifiers

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Trial sponsor

Puma Biotechnology, Inc.

Scientific Title

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting (Other ID's:PUMA-NER-1301, 2012-004492-38)

Eligibility

Inclusion

  • Aged ≥18 years at signing of informed consent.
  • Histologically confirmed MBC, current stage IV.
  • Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+, with confirmatory fluorescence in situ hybridization (FISH) +.
  • Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.

Exclusion

  • Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

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Completed hospitals

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